MAUDE Adverse Event Report: NEILMED PHARMACEUTICALS, INC. NETI POT; APPPLICATOR, ENT

Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Sore Throat (2396); Fungal Infection (2419)
Date of Event	01/11/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
After using the neti pot for sinus congestion i developed a very sore throat that wouldn't go away.I finally had a throat culture done and it showed i had an overgrowth of yeast.It was from the constant irrigation of my nose/throat and it rinsed all the "good bacteria" away and pre-disposed me to developing a throat yeast infection.Date of use: (b)(6) 2013 - (b)(6) 2017.Diagnosis or reason for use: chronic nasal congestion, sinusitis.Is the product over-the-counter: yes.Event abated after use stopped or dose reduced: yes.

• Brand Name: NETI POT
• Common Device Name: APPPLICATOR, ENT
• Manufacturer (Section D): NEILMED PHARMACEUTICALS, INC.
• MDR Report Key: 6278908
• Report Number: MW5067449
• Device Sequence Number: 1019576
• Product Code: KCJ
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Weight: 66